Technology titan Apple Inc. (NSDQ:AAPL) sent a few executives to the FDA late last year to meet with agency officials to talk about "mobile medical applications," according to the FDA’s public calendar.
Representatives from Apple included senior vice president of operations Jeff Williams, vice president of software technology Bud Tribble and former Masimo (NSDQ:MASI) chief medical officer Michael O’Reilly, the New York Times reported. Agency officials included Commissioner Margaret Hamburg, medical device chief Dr. Jeffrey Shuren and mobile medtech policy maker Bakul Patel.
Neither the FDA nor Apple commented on the Times’ coverage, but life sciences lawyer Mark McAndrew of Taft Stettinius & Hollister told the paper that the high-profile roster suggested either that Apple is forging a new regulatory relationship with the FDA or that it’s hashing out hangups over an existing bid for approval.
Apple’s meeting, which apparently took place December 13, adds more fire to the speculation over Apple’s highly anticipated "iWatch" technology, which the company has yet to announce or confirm. The smartwatch is expected to run a variation of Apple’s existing operating system and may allow for app development. Reports of Apple’s increasing interested in health monitoring systems have fueled rumors that the watch will include medical data capture and tracking.
Adding to that speculation are rumors, that appear now confirmed, that Masimo’s former CMO O’Reilly joined the tech giant in 2013. O’Reilly was rumored to have left patient monitoring systems maker Masimo for Apple some time last year.
O’Reilly had been chief medical officer at Masimo since 2008, and he still serves on the board of Masimo’s Foundation for Ethics, Innovation & Competition in Healthcare, according to the group’s website. Masimo last year debuted its iPhone pulse oximeter, the 1st Apple-approved pulse oximetry system compatible with iPods, iPhones and iPads.
Apple also recently hired a couple of other medical sensor experts, including Nancy Dougherty, formerly involved with transdermal drug delivery devices and wearable vital signs monitoring, and Ravi Narasimhan, who also worked with personal vital signs monitoring.
The company early this year also landed a patent for a smartphone heart sensor, although that application laid out plans to use the sensor primarily for personalization and authentication.
Fellow tech giant Google’s (NSDQ:GOOG) was caught early this year on the FDA’s public calendar as well, leading to rampant conjecture that resolved with the company’s announcement that it was building "smart" contact lenses that could detect and wirelessly transmit blood glucose data to a smartphone or other mobile technology, potentially replacing finger-prick blood testing for diabetics.
